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Completed

NCT Number: NCT01792414

Transcranial Electrical Stimulation (TES) for the Treatment of Depression.

This study is a RCT of transcranial electrical stimulation in depressed patients. Mood, cognitive test performance and biomarkers will be measured during the trial.

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Key information

Conditions

Major Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Black Dog Institute / University of New South Wales

Sydney, New South Wales, 2031, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • DSM-IV Major Depressive Episode (as part of a Major Depressive Disorder or Bipolar Disorder), of minimum 4 weeks duration.
  • MADRS score ≥ 20 at study entry.

Exclusion criteria

  • DSM-IV psychotic disorder;
  • drug or alcohol abuse or dependence (preceding 12 months);
  • inadequate response to ECT (current episode of depression);
  • anticonvulsant or benzodiazepine medication;
  • rapid clinical response required, e.g. high suicide risk; clinically defined neurological disorder or insult;
  • metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites;
  • pregnancy.

Treatment and study plan

Sham tES

Device

Neuroconn Eldith device

Active tES

Device

Neuroconn Eldith device

Primary outcomes

  1. Montgomery Asberg Depression Rating Scale for Depression (MADRS)

    Time frame: 12 weeks

Secondary outcomes

  1. Beck Depression Inventory II

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

The University of New South Wales

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Feb 15, 2013
Registry last updated
Feb 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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